Description overdue on 08/11/2014

  • Latin name: Protopic
  • ATC code: D11AH01
  • Active substance: Tacrolimus (Tacrolimus)
  • Manufacturer: Astellas Pharma Europe B.V. (Netherlands)
Photos of the drug
Tweet
  • Composition
  • Product form
  • Pharmacological action
  • Pharmacodynamics and pharmacokinetics
  • Indications
  • Contraindications
  • Side effects
  • Instructions for use Protopic (method and dosage)
  • Overdose
  • Cooperation
  • Terms of sale
  • Storage conditions
  • Shelf life
  • Analogs
  • Reviews
  • Price, where to buy

 Protopic

Composition

Protopic ointment (Protopic) has the following composition:

  • active substance - tacrolimus   monohydrate;
  • Additional components - white soft paraffin . propylene carbonate . solid paraffin . Liquid paraffin . beeswax white .

Product form

The drug is sold in plastic tubes, which are contained in cardboard packs.

Pharmacological action

Dermotropic   means.

Pharmacodynamics and pharmacokinetics

Protopic is an inhibitor of calcineurin . The drug binds to a cytoplasmic protein Immunophilins Which is cytosolic   receptor for calcineurin . In this created a complex that includes tacrolimus .   calcium .   calcineurin . immunophilin   and calmodulin . This causes inhibition of phosphatase activity calcineurin That prevents the dephosphorylation and translocation of nuclear factor of activated T cells Which is needed to initiate gene transcription Encoding products Cytokine Important for T-cell immune response .

The active substance also inhibits ointment gene transcription Which encode products IL-3 . IL-4 . IL-5 ( Cytokines ). Furthermore, it inhibits:

  • GMKSF   and TNF-α Involved in activation T-lymphocyte ;
  • decreased expression FcεRI   on Langerhans cells   (leading to a decrease in their activity);
  • release inflammatory mediators   from mast cells . eosinophils   and basophils .

This tool does not provoke atrophy   skin.


Absorption   into the systemic circulation when topically outer minimal. Systemic absorption depends on the area affected. It is reduced to the extent that, as the symptoms disappear dermatitis .

The active substance of Protopic is not biotransformed in the skin. When penetrating into the systemic circulation it is cleaved in the liver.

Prolonged local application of the drug half-life is 65 hours for children and 75 hours in adult patients.

Indications

The drug is used for treatment atopic dermatitis If other means for external application were not effective or patients have contraindications to them. Sometimes cream is prescribed if treatment is necessary vitiligo .

Contraindications

This tool can not be used when:

  • significant violations epidermal barrier ;
  • breast-feeding ;
  • pregnancy ;
  • children under two years of age;
  • Children up to age 16 years (cream 0, 1%);
  • Hypersensitivity to the components of the drug.

Precautions drug is given to people with decompensated hepatic insufficiency As well as extensive lesions of the skin.

Side effects

As a rule, when using Protopic may appear as side effects   symptoms of irritation of the skin   at the site of application. Typically, they are characterized by moderate severity and tested one week after initiation of therapy.

Furthermore, it can be observed alcohol intolerance   and an increased likelihood of folliculitis . herpetic infection   and acne . Also, there are the following side effects:

  • a feeling of warmth to the place of use;
  • itching ;
  • paresthesia ;
  • hyperesthesia .

In rare cases, there were cases Rosacea   and malignancy .

Instructions for use Protopic (method and dosage)

Instructions on Protopic reported that the cream should be applied externally. It should be applied to the affected area of ​​the skin, but not on mucous and under an occlusive dressing.

Children 2-16 years old have to apply ointment 0 03% 2 times / day. The maximum duration of treatment - 3 weeks. Subsequently, if necessary, the frequency of application should be reduced to 1 times per day. Treatment continues until you have eliminated all lesions.

Instructions for use ointments for adults and adolescents recommends starting treatment with cream 0, 1% 2 times / day to the disappearance of all lesions. As the disease will be possible to reduce the frequency of application, or go on a cream 0, 03%. If the manifestations of disease return, therapy ointment 0, 1% to resume twice a day. When allowing the clinical picture, it is necessary to apply the medication less frequently or go to salve 0, 03%.

As a rule, already noticeable improvement after one week of treatment. If they are absent for two weeks of therapy, it is necessary to consider the use of other means.

In exacerbations of ointment can be used for a short or long-term in the form of courses, repeated with some frequency. Lubricate the affected area of ​​the skin you need to absolute disappearance of symptoms. Generally improved markedly after the first week of therapy. If two weeks in the clinical manifestations of the disease have not decreased, it is necessary to consider the option other means.

For the prevention of relapse (if the patient has acute atopic dermatitis   more than four times a year) is admissible maintenance therapy with ointment. Scheme of use - twice a week, apply to the affected area of ​​the skin. Interval between the application of - at least 2-3 days. Protopic is used if this was visible to its effectiveness in the use of the standard scheme.

For adults and children from 16 years shown ointment 0, 1%, for children up to 16 years - cream 0, 03%. If there are signs of deterioration, you must go to the standard application circuit.

Supportive therapy lasts 12 weeks, then you need to evaluate the clinical dynamics and decide whether you want to use this tool. In children, it should be temporarily suspend the drug.

Overdose

No cases of overdose with topical agent was observed.

If the drug was inside, need to monitor the vital signs and observe the general condition of the patient. Do not induce vomiting or gastric lavage carried out.

Cooperation

The active ingredient of the drug is not biotransformed in the skin, which eliminates the possibility of adverse interactions with other medications.

Vaccination is preferably carried out before treatment Protopic or two weeks after its completion. When live attenuated vaccine   wait after the end of application of the cream should be up to 4 weeks. If this is not possible, consider using other vaccines.

Terms of sale

The drug is sold under the prescription of a specialist.

Storage conditions

Store this medication should be out of reach for small children, at a temperature no higher than 25 ° C.

Shelf life

Three years.

Analogs of Protopic

Match code ATC 4th level:
  •  Protopic
 Elidel

The most common analogs ointment:

  • Advagraf ;
  • Prograf ;
  • Vingraf ;
  • Tacrolimus .

All counterparts Protopic have their own particular application. Replace them only in the appointment of a specialist.

Reviews of Protopic

Protopic ointment Reviews you can meet the most different. As a rule, those who have already tried this remedy on himself, reported that it helped them. However, very often there are reports that using the cream there is a strong itching, pain, redness and other undesirable effects on the skin.

In addition, forums are often asked, hormonal or not this drug. Patients with atopic dermatitis   fear of side effects that may occur with prolonged use of the tool. Experts hasten to reassure them - medication is not hormonal. However, as corticosteroid hormones It may negatively influence the plan immunity   human.

Reviews of Protopic reported that the tool helps in an average week. There are, however, negative opinions. Such reviews about Protopic leave those for whom it was not effective. These people suffer from the symptoms of adverse reactions on the skin, but the action of the ointment have not noticed. Also, some patients have expressed concern over the fact that this may cause cancer.

Price Protopic where to buy

The cream can be found in many, including foreign pharmacies. Price Protopic 0, 1% - about 1,600 rubles. And buy ointment 0, 03% can be an average of 1,500 rubles. Such price Protopic for many is too high. Therefore, patients are often interested in analogues of the tool. However, most of them cost as high as the price Protopic ointment.

Get the best price and buy